All good HPLC methods begin with a development stage. In this stage, the analyst may look at the particular analyte and determine if it can be detected with the available detector in that laboratory. Analysts must then determine the concentration in the final product that they are to analyze. Standard preparations can be made and then chromatograms should be evaluated to determine if they are acceptable (proper peak shape, etc.). The sample should then be prepared and chromatographed. There should be no peaks obstructing the analyte peak and the near by peaks should be well resolved.
HPLC methods for analytical work within a cGMP laboratory require validation. The method is checked for linearity, accuracy, precision, selectivity, and limits of quantitation and detection. These aspects help to ensure that the method will perform correctly in the long term.
The end goal of any analytical method is for the analyst to be able to use it for its intended purpose. At this stage, the analyst can use the method for analysis of the product during normal routine. This is the most useful and rewarding step of the process.